Urinary incontinence is a condition characterized by involuntary loss of urine beyond the individual's control. One cause for this loss of control is damage to the urethral sphincter caused by, for example, prostatectomy, radiation therapy or pelvic accidents. Other causes of incontinence include bladder instability, over-flowing incontinence and fistulas.
Current approaches to alleviate the incontinence include prostheses, such as slings, that exert a force on the urethra to prevent unintentional voiding of the bladder or artificial sphincters. Simply, the sling (whether it be two armed or more) is secured to the patient's tissue such that the urethra is supported by the sling. The sling applies pressure to the urethra to prevent unwanted discharge of urine.
One approach provides an artificial sphincter that has an inflatable cuff that fits circumferentially around the urethra near where the urethra joins the bladder. A balloon regulates cuff pressure and a bulb controls inflation and deflation of the cuff. The balloon is surgically placed within the pelvic area, and the control pump is placed in the scrotum.
The cuff is inflated to keep urine from leaking. When urination is desired, the cuff is deflated, allowing urine to drain out.
Urethral slings include those disclosed, for example, in U.S. Pat. Nos. 7,621,864, 7,611,454, 7,431,690 and 7,422,557 and U.S. Patent Publication Nos. 2005/0283040, 2006/0052800, 2006/0122457, and US 2010/0197998, the contents of which are included in their entirety.
Inflatable balloons are also known in the art. They can be used in connection with erectile dysfunction or with urethral prostheses. Suitable inflatable balloon technology includes that disclosed in U.S. Pat. Nos. 4,566,446, 5,062,417, 5,250,020, 5,851,176, 5,895,424, 6,171,233 and 4,982,731 and U.S. Patent Publication Nos. 2006/224039, 2007/0142700 and 2007/106897, the contents of which are included in their entirety.
Artificial sphincters are disclosed in PCT Publication Nos. WO 2005/009293, WO 2006/012653, WO 2004/096087 and WO 98/31301 and U.S. Pat. Nos. 5,163,897, 5,634,878 and 6,786,861, the contents of which are included in their entirety.
Combinations of slings with inflatable balloons are also known in the art. They include those disclosed in Danish application PA 2009 00718, filed Jun. 8, 2009, entitled “Anatomical Augmentation Device”, U.S. Pat. Nos. 7,395,822, 6,786,861, 7,395,822, 7,608,067 and 7,273,448 and U.S. Patent Publication Nos. 2004/0215054 and 2007/0049790, the contents of which are included in their entirety.
For example, a fluid filled chamber is incorporated into the prosthesis to provide improved treatment of incontinence. U.S. Pat. No. 6,502,578 and U.S. Published Patent Application 2001/0023356, report an apparatus and method for treatment of male incontinence in which a “hammock-like” prosthesis is positioned between the descending rami of the pubic bone. The prosthesis includes an inflatable balloon device positioned to provide passive compression on the bulbar urethra to prevent voiding of the bladder. The volume of the balloon may be adjusted after implantation in a patient with a introducer and syringe device.
Suitable slings may include a Virtue® male sling (Coloplast Corp., 601 West River Road North, Minneapolis, Minn. 55411) which comprises two transobturator arms and two prepubic arms. In known techniques, a J-hook needle is required to place the transobturator arms of the sling. This same needle is often used for the tunneling technique to place the prepubic arms of the sling. If the J-hook needle is not used, a tonsil clamp is often recommended for the tunneling of both the transobturator arms and prepubic arms. The prepubic arms of a sling are placed about 10 cm apart from one another, about 5 cm from the midline in the patient's prepubic region.
One disadvantage that arises from the current process is the tunneling required between the prepubic arms. When the prepubic arms are spaced about 10 cm apart it becomes difficult to pass the J hook needle. An instrument such as a tonsil clamp must then be used to pass through the subcutaneous tissues, from the first prepubic incision to the second prepubic incision. This is then repeated for the other prepubic arm from the second prepubic incision to the first prepubic incision.
Other techniques may use a Stamey needle (Cook Medical, Bloomington, Ind. 47402-4195) or a Raz needle (Cook Medical, Bloomington, Ind. 47402-4195) instead of a J hook needle and tonsil clamp. A Stamey or Raz needle may be placed through the prepubic incision and guided out through the perineal incision on the ipsilateral side. The traction sutures from this side are then attached to the needle and withdrawn in the reverse process. The process is then repeated for the contralateral side. Once the prepubic arms are in place and the tensioned properly, the arms need to be tunneled in a crossover fashion. The needle is placed in the prepubic incision and tunneled to the opposite prepubic incision. The sling is attached to the needle and withdrawn. The procedure is then reversed for the contralateral side.
Alternatively, a “one pass” tunneling technique for the prepubic arms has been developed. After the prepubic arms have been placed and tensioned, the Raz or Stamey needle is attached to the ipsilateral traction suture of the sling. The needle is passed in a “cross-over” fashion. The traction suture is removed and the traction suture is attached to the needle, and this needle is withdrawn. Now, both arms are placed and only one pass of the needle has been used. This decreases the amount of tissue damage and greatly reduces intraoperative times. Using this technique, the procedure can be completed in 20 minutes or less.
A looped suture is currently attached to all four arms of the sling through a hole in the tip of a Stamey or Raz needle. On a Raz needle, the looped suture from the Virtue male sling is easily passed through this aperture. This loop is then placed over the tip of the needle and pulled tight in a “slip knot” fashion. On a Stamey needle, the hole present on the end is too small to accept the looped suture from the sling.
The needle may then be passed, initially, from the prepubic incision and guided through the perineal incision. Both the Stamey and Raz needle have a wide handle used to grasp. Although these handles make the needles easy to grasp and manipulate, they cannot be passed completely through the incision without significant tissue dissection and trauma. This makes the “top-down” approach necessary.